ITMCTR2100004838
Recruiting
Phase 1
Pilot randomised double-blind placebo-controlled trials of Wuzhuyu Decoction in relieving chemotherapy-induced nausea and vomiting of breast cancer
Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine0 sitesTBD
Conditionsbreast cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- breast cancer
- Sponsor
- Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients signed informed consent and voluntarily joined the study;
- •2\. Breast cancer was confirmed by pathology or Histocytology;
- •3\. Excluding chemotherapy contraindications, breast cancer patients who plan to receive intravenous chemotherapy drugs;
- •4\. At any time during the current chemotherapy regimen, although there were antiemetic drugs consistent with the guidelines, there was significant CINV. The specific criteria were: nausea and vomiting or the need for more than one supplementary antiemetic drug, and / or \>\= moderate nausea on the 5\-level scale (0 \= none, 1 \= mild, 2 \= moderate, 3 \= severe, 4 \= very severe);
- •5\. The patient's ECoG status was 0, 1 or 2;
- •6\. The researchers determined that the patient could be treated with Wuzhuyu decoction;
- •7\. Aged \>\=18 years;
- •8\. Life expectancy greater than or equal to 4 months;
- •9\. Willing and able to comply with all research requirements, including treatment, time and nature of assessment required, including diary, quality of life, urine test and any statutory blood test.
Exclusion Criteria
- •1\. Allergic to traditional Chinese Medicine;
- •2\. The researcher judged other conditions not suitable for inclusion in the study;
- •3\. Symptomatic primary or secondary central nervous system malignancies;
- •4\. Symptomatic gastrointestinal obstruction;
- •5\. Disease related nausea or vomiting, need daily antiemetic treatment;
- •6\. History of epilepsy or recurrent seizures;
- •7\. Schizophrenia, other psychosis, severe personality disorder, except depression associated with underlying illness;
- •8\. Patients who are pregnant, breast\-feeding or lack of contraception. Women with fertility must have a negative pregnancy test 7 days before registration;
- •9\. Patients who participated in other clinical trials in recent 3 months.
Outcomes
Primary Outcomes
Not specified
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